UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000022172
Receipt No. R000025546
Official scientific title of the study Efficacy and safety of olanzapine suppositories in terminally ill patients with delirium or nausea and vomiting.
Date of disclosure of the study information 2016/05/02
Last modified on 2016/05/02

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Official scientific title of the study Efficacy and safety of olanzapine suppositories in terminally ill patients with delirium or nausea and vomiting.
Title of the study (Brief title) Efficacy and safety of olanzapine suppositories.
Region
Japan

Condition
Condition delirium, nausea and vomiting
Classification by specialty
Medicine in general
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 A new formulation of olanzapine available for terminally ill patients with oral feeding difficulties is needed. Rectal administration using suppositories is an alternative for patients for whom administration via the oral route is not feasible. So, we prepare olanzapine suppositories and evaluate the clinical efficacy and safety of olanzapine suppositories used to treat patients with delirium, vomiting, or nausea.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Responses to olanzapine therapy are evaluated based on clinical assessments by physicians. Information about the side effects is extracted from the electronic medical records of each patient.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Patients use olanzapine suppositories as a treatment for delirium or nausea and vomiting at the time of oral feeding difficulties. Patients are administered 2.5 mg, 5 mg, and 10 mg of olanzapine suppositories.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria We selected to treat for delirium or nausea and vomiting in terminally ill cancer patients with oral feeding difficulties.
Key exclusion criteria We exclude children and patients with taking orally.
Target sample size 50

Research contact person
Name of lead principal investigator Masayuki Miyazawa
Organization Shonan Central Hospital
Division name Pharmacy
Address 1-3-43 Hatori, Fujisawa-si, Kanagawa, Japan
TEL 0466-36-8151
Email miyazawa@swg.or.jp

Public contact
Name of contact person Masayuki Miyazawa
Organization Shonan Central Hospital
Division name Pharmacy
Address 1-3-43 Hatori, Fujisawa-si, Kanagawa, Japan
TEL 0466-36-8151
Homepage URL
Email miyazawa@swg.or.jp

Sponsor
Institute Shonan Central Hospital
Institute
Department

Funding Source
Organization No
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Division of Practical Pharmacy, Keio University Faculty of Pharmacy
Name of secondary funder(s)

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2016 Year 05 Month 02 Day

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2015 Year 01 Month 01 Day
Anticipated trial start date
2015 Year 01 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2016 Year 05 Month 02 Day
Last modified on
2016 Year 05 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025546

Research Plan
Registered date Registrant File name

Research case data specifications
Registered date Registrant File name

Research case data
Registered date Registrant File name


For inquiries about the use of UMIN clinical trial registration system, use this contact form .Fort other inquiries, use this contact form